ISPE-CaSA kicks off the New Year with an education seminar focused on Automation
with our featured education sponsor NNE
Brendan Bradley, Regional Sales Manager, Vanrx Pharmasystems,
Pete Durand, Automation Leader, Subject Matter Expert
Thomas Jacobsen, Automation Engineer, NNE
Thai Le, Automation Engineer, Novo Nordisk
Aseptic Filling Workcells—Gloveless Robotic Isolators for Aseptic Filling - Vanrx Pharmasystems How automation advances in other industries are applied to meet important needs in pharmaceutical manufacturing, specifically flexibility, process control and sterility assurance. Robotics, machine vision, and gloveless isolator technologies are integrated to form a highly automated aseptic process. Vials, syringes and cartridges can be processed on a single system, with the traditional causes of human interventions designed out of the filling and closing process. Participants will learn from customer case studies about the implementation and use of these technologies in the production of biologics and personalized medicines. Brendan Bradley, Regional Sales Manager, Brendan Bradley is an experienced sales professional who has spent almost a decade in the biopharma space in multiple sales and account management roles. Currently, Brendan is in his 3rd year with Vanrx Pharmasystems and has worked with leading biotechnology companies, generic manufactures, and CDMOs on various projects requiring highly flexible, robotic aseptic filling equipment. Brendan is routinely called in by end users that require a single piece of capital equipment that can switch rapidly between multiple drug products and formats. Previously, Brendan spent 6 years with Evoqua Water Technologies (Formerly USFilter/Siemens Water) working with engineering firms and end users on defining and implementing high purity water systems for various applications. Brendan was often brought in by end user organizations to provide training on water chemistry and various water technologies. Brendan is an active member of ISPE and serves as a volunteer for the Delaware Valley Chapter as co-chair of the education committee.
Balance Automation Standardization and Flexibility in an Agile Organization - Novo Nordisk DAPI US is the $2 billion Novo Nordisk investment in diabetes API production facility in Clayton, NC. Within any pharmaceutical manufacturing facility, automation optimization is reliant on a focused on standardized processes. Learn how a large, complex project focuses on automation modularization, empowerment, and simplifying the bidding process in order to reduce number of work flows, reduce cost and schedule. Thai Le, Automation Engineer, Representing Novo Nordisk in this discussion is Thai Le, who comes with 12+ years of Bio-pharmaceutical industry experience implementing and supporting Manufacturing Execution System (MES) systems. His broad experience spans across many perspectives, as a MES software vendor, implementer, and system manager. Currently, Thai is the Work Package Owner responsible for implementing the MES system and interfaces at NN DAPI-US project.
Enterprise Control, Industry 4.0 and IoT, what does it all really mean? Learn about the disruption emerging from the convergence of modern and legacy technologies. Gain new insights into why these technologies should be implemented and what it takes to see value. Why and how to position these technologies within your organization. Pete Durand, Automation Leader Subject Matter Expert, Pete is an exceptional leader with a passion for Automation! He has found success in previous roles as a corporate executive at leading industrial and technology firms such as Kimberly Clark, Eaton and General Electric, and has led and founded start-up companies in security and healthcare. He is an accomplished triathlete, holds a bachelor’s degree in Industrial Engineering and Master of Business Administration, and is a former Ernst & Young Entrepreneur of the Year for the Carolinas.
The Future State of Pharma 4.0 within Automation - NNE Thomas Jacobsen, Automation Engineer, Thomas Jacobsen has a M.Ch.Eng., Biomanufacturing from North Carolina State University and a B.S., Biological Engineering & Process Controls also from North Carolina State University. An Automation Engineer with over10 years of Biopharmaceutical experience, Thomas has worked with SCADA and DCS software packages including Rockwell, OSISOFT PI, VMware and Cisco Network Infrastructure. He has worked in regulatory and quality roles as a project lead and has performed statistical analysis of site performance across multiple manufacturing divisions and within divisional manufacturing sites. He has served as a Subject Matter Expert (SME) in Food and Drug Administration (FDA) inspections defending documentation and processes to inspectors and auditors. In addition to having completed Lean/Six Sigma Greenbelt training, Thomas is a Certified Corrective and Preventive Action (CAPA). He also is a VMware and Cisco Network Infrastructure SME with multiple project experience of VMware deployment.
$20 Non-Member, $15 Member, $10 Student/YP
ISA - International Society of Automation
67 TW Alexander Dr., Research Triangle Park, NC 27709
Automation Presentations: 1:00- 2:20pm
Networking/ISA Tour and Refreshments: 2:20-3:00pm
Automation Presentations: 3:00- 5:00pm
Followed by continuing networking at Therapeutic Thursday at Rookies Sports Bar, sponsored by LB Bohle